Welcome to our dedicated page for Atossa Therapeutics news (Ticker: ATOS), a resource for investors and traders seeking the latest updates and insights on Atossa Therapeutics stock.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company whose news flow centers on the development of its lead investigational therapy, (Z)-Endoxifen. Company announcements frequently cover progress in breast cancer programs, regulatory interactions, intellectual property developments, and emerging opportunities in other serious diseases.
Investors following ATOS news can expect regular updates on clinical trials involving (Z)-Endoxifen, including studies in metastatic ER+/HER2- breast cancer, neoadjuvant treatment for premenopausal ER+/HER2- patients, breast cancer risk reduction strategies focused on mammographic breast density, and participation in the RECAST DCIS platform trial for hormone receptor–positive ductal carcinoma in situ. These releases often summarize trial design, early findings, and the potential implications for future registration strategies.
Atossa’s news also highlights regulatory milestones, such as FDA Type C meetings, Investigational New Drug (IND) submissions, and “Study May Proceed” letters. Additional coverage includes the FDA’s Rare Pediatric Disease designation for (Z)-Endoxifen in Duchenne Muscular Dystrophy, as well as AI-enabled research collaborations identifying new oncology indications like glioblastoma.
Another recurring theme in ATOS news is the company’s intellectual property position, including newly issued patents for enteric oral (Z)-Endoxifen formulations and methods of use in hormone-dependent breast disorders and estrogen-related conditions. Corporate updates, such as financial results, leadership appointments, and Nasdaq listing communications, provide context on Atossa’s operational and strategic direction.
By monitoring this news page, readers can review a chronological record of Atossa’s clinical, regulatory, scientific, and corporate announcements related to (Z)-Endoxifen and the company’s broader oncology and rare disease programs.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) announces a live Q&A session on November 30, 2021, at 8 AM Pacific/11 AM Eastern. CEO Dr. Steven Quay and CFO Kyle Guse will address questions regarding Atossa's research initiatives focused on breast cancer and COVID-19. The event, hosted by Tribe Public, is complimentary, with registration available here. For more details about Atossa, visit atossatherapeutics.com.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) reported its financial results for Q3 2021, ending September 30, with cash reserves of approximately $140 million. The company has no sustainable revenue and incurred operating expenses of about $5.16 million for Q3 2021, a 47% increase year-over-year. Key developments include initiating a clinical study for AT-H201 targeting COVID-19 patients and receiving Swedish regulatory approval for a Phase 2 trial of Endoxifen in women with mammographic breast density. The company anticipates ongoing increases in R&D expenses as trials progress.
Atossa Therapeutics (Nasdaq: ATOS) CEO Dr. Steven Quay addressed the significant decline in mammograms during the global pandemic in a recent video for Breast Cancer Awareness Month. He emphasized that many women have not been seeking mammograms since COVID-19 began, which is particularly concerning for women of color and those in lower income brackets, as highlighted in a peer-reviewed article. Atossa continues to focus on innovative treatments for oncology and COVID-19, aiming to address these urgent medical needs.
Atossa Therapeutics has begun enrolling participants in a clinical study for its nebulized formulation, AT-H201, aimed at improving lung function in both moderately to severely ill hospitalized COVID-19 patients and those suffering from post-infection pulmonary issues. The study will include 60 participants and is being conducted in Australia. AT-H201 combines two FDA-approved drugs and has shown to be significantly more potent than existing treatments like Remdesivir. Successful completion of this study and obtaining regulatory approval is crucial for commercialization.
Atossa Therapeutics (Nasdaq: ATOS) adjourns a special stockholder meeting to October 7, 2021, to allow more time for voting on a proposal to increase authorized shares. Currently, 73% of voted shares support the proposal, but only 58% of outstanding shares have been voted. Leading advisory firms ISS and Glass Lewis recommend approval. The new shares aim to fund acquisitions and collaborations, with no intention to raise capital below $10 per share in the nine months following approval. Stockholders can vote via phone at (833) 786-6488.
Atossa Therapeutics (Nasdaq: ATOS) has received approval from the Swedish Ethics Review Authority to initiate a Phase 2 clinical trial of oral Endoxifen aimed at reducing mammographic breast density (MBD). MBD affects over 10 million women in the U.S. and can complicate cancer detection. The trial, named Karisma-Endoxifen, will enroll around 240 healthy premenopausal women for a six-month study period. The primary goal is to evaluate the dose-response relationship of daily Endoxifen on MBD, with secondary objectives assessing safety and tolerability.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) reported financial results for Q2 2021, ending June 30, with cash balances of $142.4 million. The company achieved significant outcomes in its Phase 2 clinical studies, notably a 65.1% reduction in Ki-67 levels in breast cancer patients. Regulatory approvals from Sweden and Australia allow for the initiation of further clinical studies of Endoxifen and AT-H201. However, operating expenses surged by 78% and R&D costs rose by 130% compared to the previous year, reflecting increased clinical trial activities.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) announces participation in the BTIG Virtual Biotechnology Conference on August 9-10, 2021. Steven Quay, President and CEO, and Kyle Guse, CFO, will engage in a fireside chat scheduled for August 9 at 10:00 a.m. ET. This event will be available for live streaming on the conference website, and a recording will follow. Investors are invited to schedule one-on-one meetings with the executives during the conference.
Atossa focuses on developing innovative treatments for unmet medical needs in oncology and infectious diseases, with emphasis on breast cancer and COVID-19.
On July 26, 2021, Steven Quay and international scientists released a pre-print paper examining the RNA sequencing data of early COVID-19 patients, suggesting severe contamination at the Wuhan Institute of Virology. Findings indicate that specimens from December 2019 contained significant levels of an undisclosed H7N9 influenza vaccine, over six times the amount of SARS-CoV-2. Additionally, Nipah virus gene sequences were identified, raising concerns about genetic manipulation. This contamination is problematic, given the lethal nature of the pathogens involved.
An international team of scientists, led by Dr. Steven Quay, has published a paper suggesting that a laboratory-acquired infection could be a more likely origin of COVID-19 than natural zoonotic transmission. The paper, presented to the US Congress, highlights insufficient biosafety levels in Wuhan labs and the absence of animal-to-human transmission evidence. Dr. Quay advocates for treating the lab leak theory as the primary hypothesis until new evidence emerges. Quay, a prominent figure in medicine, has contributed significantly to pharmaceuticals and pandemic survival strategies.